*Remote* - Principal Scientist/Director - Analytical MSAT - Cell-Based Assay's Life Cycle

Northreach is a dynamic recruitment agency that connects businesses with top talent in the Advanced Therapies sector. Our mission is to provide a seamless and personalised recruitment experience for clients and candidates, and to create a positive work environment that encourages equality, innovation, and professional growth.

Responsibilities

• Provide support for the management of outsourced analytical methods across a global network of vendors involved in the manufacturing of commercial and clinical Protein/mAb based drug substances and drug products.
• Provide oversight and expertise for external manufacturing operations relating to bioassays such as ADCC, CDC, ELISA, SPR, ELISA, ELISPots, etc. and Cell-based binding and potency assays.
• Assist in shaping the strategy and effectively oversee the execution of assay validation from development, transfer, optimization, and then to commercial and Clinical manufacturing.
• Collaborate with colleagues in QC, QA, Process Development, MSAT, Drug product and other in-house/external teams.
• Oversee and manage both development and Good Manufacturing Practice (GMP) analytical activities conducted in external laboratories.
• Contribute to the preparation and review of CMC (Chemistry, Manufacturing, and Controls) documentation, particularly focusing on the analytical sections required for regulatory filings(BLA/MAA), including post-approval submissions to US and EU regulatory bodies.
• Coordinate efforts with compliance groups, including QC testing, QA, and regulatory teams, to ensure alignment with regulatory standards and quality assurance.
• Conduct in-depth analysis and trend evaluation of testing results, presenting findings in a clear and data-driven manner, and proposing actionable solutions based on these insights.
• Author and review technical reports and other documentation in a clear and concise manner, ensuring that all information is accurately conveyed.

Qualifications

• PhD in Biology Chemical engineering, or related area. 4+ years of experience in Analytical Development for Protein based products, industry is strongly preferred (M.S. with significant industry experience will also be considered)
• Experience managing the entire cell-based assay lifecycle from development, Tech transfer, to commercial and being involved in the BLA/MAA regulatory submissions.
• Bench experience with Cell-based assays and assay progression.
• Experience transferring to quality control (qualification/validation) and tech transfer to commercial settings.
• Experience in overseeing outsourced analytical tasks remotely within the pharmaceutical development or commercial sector, encompassing method development, validation, and transfer processes.
• Strong experience managing external manufacturing operations at CMO's/CRO's/CDMO's in relation to bioassays such as ADCC, CDC, ELISA, SPR, and Cell-based binding assays.
• Knowledgeable about cGMP (current Good Manufacturing Practice) requirements pertaining to the analysis of biopharmaceuticals.
• Demonstrated experience in managing both development and GMP work in external analytical labs (or in house manufacturing lab in GMP environment).
• Possesses a robust scientific mindset and communication skills while maintaining the ability to skilfully interpret data to construct and convey insights into assay and product behaviour.
• A proactive attitude, capable of addressing challenges effectively, and a willingness to be part of a dynamic, team-oriented environment within a small but expanding commercial stage biotechnology company, offering diverse opportunities for personal and professional development.

Northreach is an equal opportunity employer and we do not discriminate against any employee or applicant for employment based on race, colour, religion, sex, national origin, disability, or age. We are committed to promoting diversity, equity, and inclusion in the workplace and hiring practices, therefore only partner with business that promote DEI. We strive to create a welcoming and inclusive environment for all employees.